Parte Seconda n. 73 del 27-6-2015
Altri annunzi
Specialita' medicinali, presidi sanitari e medico chirurgici
JANSSEN-CILAG S.P.A.
Sede: via M. Buonarroti, 23 - 20093 Cologno Monzese (MI)
(GU Parte Seconda n.73 del 27-6-2015)

Modifiche secondarie di un'autorizzazione all'immissione in commercio
di medicinale per uso umano, apportata ai sensi del D.L. 29 dicembre
2007, n. 274. Modifiche apportate ai sensi del regolamento
1234/2008/CE e s.m.


Titolare AIC: Janssen-Cilag S.P.A.
Ai sensi della determinazione AIFA 18 dicembre 2009, si informa
dell'avvenuta approvazione delle seguenti variazioni:
Medicinale: TOPAMAX
Confezioni e numeri di AIC: tutte - AIC AIC 032023
Codice pratica: C1B/2015/652- SE/H/0110/001-04,07-09/IB/072
C.I.11.z Introduction of changes to the obligations and conditions
of a marketing authorization, including the risk management plan
DA: RMP v3 dated 05th March 2014 - A: RMP v4 dated 19th March 2014
Confezioni e numeri di AIC: 15-25 mg capsule - AIC AIC
032023(083)-(095)
Codice pratica: C1B/2015/815 - SE/H/110/007-009/IB/73/G
B.III.1 Submission of a new or updated Eur. certificate of
suitability or deletion of Ph. Eur. certificate of suitability for an
excipient (gelatin)
DA: R1-CEP 2000-027-Rev 01 - A: R1-CEP 2000-027-Rev 02
DA: R1-CEP 2001-332-Rev 01 - A: R1-CEP 2001-332-Rev 02
Medicinale: RISPERDAL
Confezioni e numeri di AIC: 1-2-3-4 mg compresse rivestite con film
e 1 mg/ml gocce orali, soluzione - AIC 028752
Codice pratica: C1A/2015/1024 - DE/H/2184/002-008/IA/044
B.II.b.1.a Addition of a manufacturing site for part or all of the
manufacturing process of the finished product. Secondary packaging
site: Janssen Pharmaceutica NV
Rue du Bois de la Hutte 7, 7110 La Louviere, Belgium
Confezioni e numeri di AIC: 1-2 mg compresse orodispersibili - AIC
028752
Codice pratica: C1A/2015/1279 - DE/H/2184/009-012, 016/IA/045/G
A.5 Change in the address of a manufacturer/importer of the
finished product (including batch release or quality control testing
sites)
DA: Janssen-Cilag S.P.A. Via C. Janssen, Borgo S. Michele - 04010
Latina, Italy
A: Janssen-Cilag S.P.A. Via C. Janssen, Borgo S. Michele - 04100
Latina, Italy
B.II.b.1.a Addition of a manufacturing site for part or all of the
manufacturing process of the finished product. Secondary packaging
site: Janssen Pharmaceutica NV
Rue du Bois de la Hutte 7, 7110 La Louviere, Belgium
B.II.d.2.a Change in test procedure for the finished product. Minor
changes to an approved test procedure
DA: Test method DS-TMD-1277. System Suitability: Resolution factor
(R) between R082355/T001624 and R076960 in Selectivity Solution is
greater than or equal to 1.5 as calculated by the current USP
(Section &lt; 621 &gt; Peak Width at base) at beginning and end of the
analysis sequence.
A: Test Method DS-TMD-1277. System Suitability: Resolution factor
(R) between R082355/T001624 and R076960 in Selectivity Solution is
greater than or equal to 1.8 as calculated by the current USP
(Section &lt; 621 &gt; Peak Width at base) at beginning and end of the
analysis sequence.
Medicinale: RISPERDAL
Confezioni e numeri di AIC: 25-37,5-50 mg/2ml polvere e solvente
per sospensione iniettabile a rilascio prolungato - AIC 028752
Codice pratica: C1A/2015/1417 - DE/H/2184/013-015/IA/46/G
B.II.b.1.a Addition of a manufacturing site for part or all of the
manufacturing process of the finished product. Secondary packaging
site: Janssen Pharmaceutica NV
Rue du Bois de la Hutte 7, 7110 La Louviere, Belgium
B.II.b.3.a Change in the manufacturing process of the finished
product, including an intermediate used in the manufacture of the
finished product. Minor change in the manufacturing process:
- Addition of a new microsphere filling line at Alkermes, Inc. with
a subsequent new automated fill verification in-process test.
- Manufacturing bulk line #1 used in the manufacture of risperidone
microspheres has been decommissioned.
B.II.b.5.b Change to in-process test(s) or limits applied during
the manufacture of the finished product. Addition of a new test(s)
and limits: in-process test of the weight of each vial is now
performed in-line. It is measured after the risperidone microspheres
are filled into a vial.
B.II.d.2.a Change in test procedure for the finished product. Minor
changes to an approved test procedure. Correction to the previously
filed endotoxin analytical method for the diluent:
DA: Method D, kinetic chromogenic of Ph. Eur. 2.6.14
A: Method C, kinetic turbidimetric of Ph. Eur. 2.6.14
Medicinale: EPREX
Confezioni e numeri di AIC: tutte - AIC 027015
Codice pratica: C1A/2015/890 - FR/H/003/09-10, 13-014/IAin/114
B.II.b.1.a Addition of a manufacturing site for part or all of the
manufacturing process of the finished product. Secondary packaging
site: Janssen Pharmaceutica NV
Rue du Bois de la Hutte 7, 7110 La Louviere, Belgium
I lotti già prodotti possono essere mantenuti in commercio fino
alla data di scadenza indicata in etichetta.

Un procuratore
dott.ssa Alessandra Sinibaldi


T15ADD9175